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Replace Glycemic Load and Satiety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516333
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : December 18, 2015
General Mills
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Brief Summary:
The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.

Condition or disease Intervention/treatment Phase
Glucose Blood Glycemic Index Other: High GL 107 Other: Medium GL 76 Other: Medium GL 68 Other: Low GL 48 Phase 1

Detailed Description:
The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1
Study Start Date : February 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Diet 1
High GI; High Carb; High GL
Other: High GL 107
Three meals a day

Experimental: Diet 2
High GI, Low Carb, Med GL
Other: Medium GL 76
Three meals a day

Experimental: Diet 3
Low GI, High Carb, Med GL
Other: Medium GL 68
Three meals a day

Experimental: Diet 4
Low GI, Low Carb, Low GL
Other: Low GL 48
Three meals a day

Primary Outcome Measures :
  1. Blood Glucose over time [ Time Frame: 1 month ]
    Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.

Secondary Outcome Measures :
  1. Visual Analog scores (VAS) [ Time Frame: 1 month ]
    Hunger, satiety, and vigor will be measured by the visual analog scales.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body Mass index between 25-35 kg/m2
  • Fasting serum glucose
  • Fasting serum glucose < 125 mg/dl
  • Free of chronic disease
  • Willing to eat only the foods that are provided by the Center during the diet periods
  • Willing to abstain from the consumption of alcohol during the diet periods
  • Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
  • Monophasic birth control (same dose each day)
  • Hormone replacement therapy
  • Post-menopausal (over 1 year without bleeding)
  • Have had partial hysterectomy over the age of 55
  • complete hysterectomy at any age

Exclusion Criteria:

  • Documented presence of atherosclerotic disease
  • Diabetes mellitus
  • Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
  • Body Mass Index <25 or > 35
  • History of drug or alcohol abuse in the last year
  • For women, pregnancy, breast feeding or postpartum < 6 months
  • History of depression or mental illness requiring treatment or medication within that last 6 months
  • Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
  • Lifestyle or schedule incompatible with the study protocol
  • Planned continued use of dietary supplements through the study trial
  • Smoking or tobacco use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516333

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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
General Mills
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Principal Investigator: Frank L Greenway, MD Pennington Biomedical Research Center
Study Chair: William Cefalu, MD Pennington Biomedial Research Center
Principal Investigator: Marlene M Most, PhD, RD Pennington Biomedical Research Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Frank Greenway, Medial Principal Investigator, Pennington Biomedical Research Center Identifier: NCT01516333    
Other Study ID Numbers: PBRC 26026
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
glycemic Index